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Status Epilepticus Therapy Granted Fast Track Status

SAGE Therapeutics announced that the FDA has granted Fast Track status to SAGE-547 for the treatment of adult patients with refractory status epilepticus (super-refractory status epilepticus, or SRSE) who have not responded to standard regimens. SAGE-547 is an allosteric modulator of GABAA receptors.

SAGE is currently evaluating SAGE-547 in a Phase 1/2 clinical trial as adjunctive therapy for the treatment of SRSE. Preliminary data indicate that the first four patients enrolled in the clinical trial met the key efficacy endpoint, in that each was successfully weaned off his or her anesthetic agent while SAGE-547 was being administered.